Effect of AV Distraction and Acuapoint Stimulation in Pediatric Extraction on Pain and Anxiety (AV Acupoint)

January 19, 2026 updated by: Mansoura University

Effectiveness of Audiovisual Distraction and Acuapoint Stimulation on Anxiety and Pain Perception During Tooth Extraction in Children: A Randomized Controlled Clinical Study.

The aim of this study is to evaluate the effectiveness of audiovisual distraction and acuapoint stimulation on anxiety and pain perception during tooth extraction in children.

Study Overview

Status

Enrolling by invitation

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

69

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Egypt
      • Al Mansurah, Egypt
        • Faculty of Dentistry Mansoura University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • 1- Children with behavior rating score 2,3 according to Frankl's behavior rating scale.

    2- Children aged 5-8 years requiring primary tooth extraction. 3- Healthy children free of systemic diseases

Exclusion Criteria:

  • 1- Children with special health care needs.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: dental story
A dental video story will be presented to patient using an iPad device connected to a noise cancellation headphone.
Device: Audiovisual
A dental video story will be presented to the patient using an iPad device connected to a noise cancellation headphone.
Experimental: Aculief
Aculief acupressure device will be placed on the LI4 Point which is located on the hand between the thumb and index finger, also described as the depression where the index finger and thumb bone go apart. The LI4 point will be identified in each patient by asking the patient to adduct the thumb and index finger. The duration will be 5 minutes before LA administration. to patients
Device: Acualief

Aculief acupressure device will be placed on the LI4 Point (figure 1) which is located on the hand between the thumb and index finger, also described as the depression where the index finger and thumb bone go apart. The LI4 point will be identified in each patient by asking the patient to adduct the thumb and index finger. The duration will be 5 minutes before LA administration.

The administration of local anesthesia in all groups will be achieved by 1.8 ml of 2% Lidocaine with 1/100,000 epinephrine using a 30-gauge long needle
Experimental: TSD
This group will be treated using Tell-show-do technique
Behavioral: TELL SHOW DO
This group will be treated using Tell-show-do technique

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Anxiety
Time Frame: Will be measured 5 minutes before LA , immediately before extraction and immediately after extraction The total VPT score was obtained by summing the values across all eight panels, with higher scores indicating greater levels of anxiety (range: 0-8).

Anxiety will be measured by A) Pulse oximeter: Pulse oximeter was used to observe the physiological functions like heart rate and SpO₂.

B) Venham's picture test: the child was presented with eight different cards. Each card held two pictures-a representation of the child expressing anxiety along with another representation of the same child in a relaxed mood. The child was asked to point out the picture in each pair that resembled how he/she was feeling. There was also an order in which the pictures had to be presented. Assigning the image depicting anxiety the score of 1 and the relaxed image the score of 0 helped in the coding process.
Will be measured 5 minutes before LA , immediately before extraction and immediately after extraction The total VPT score was obtained by summing the values across all eight panels, with higher scores indicating greater levels of anxiety (range: 0-8).

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pain of the patient
Time Frame: Will be evaluated immediately after the local anesthesia and tooth extraction using Wong Baker FACES Pain rating scale, ranging from a no pain (score 0) to one showing severe pain (score 5)
will be evaluated by Wong baker FACES pain scale which is consist of six faces numbered ordinary from 0 to 5. ranging from a no pain (score 0) to one showing severe pain (score 5)
Will be evaluated immediately after the local anesthesia and tooth extraction using Wong Baker FACES Pain rating scale, ranging from a no pain (score 0) to one showing severe pain (score 5)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Mansoura University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 2, 2025

Primary Completion (Actual)

July 15, 2025

Study Completion (Estimated)

February 15, 2026

Study Registration Dates

First Submitted

January 11, 2026

First Submitted That Met QC Criteria

January 19, 2026

First Posted (Actual)

January 28, 2026

Study Record Updates

Last Update Posted (Actual)

January 28, 2026

Last Update Submitted That Met QC Criteria

January 19, 2026

Last Verified

January 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • A03012024PP

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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